Facilitating Migraine Medication Adherence and Optimizing Medication Use

Headache Clinical Trial

Official title:

Examining Feasibility and Effectiveness of an Internet-based Intervention for Facilitating Migraine Medication Adherence and Optimizing Medication Use

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02473692
• Other study ID #: MK-0974
• Status: Withdrawn
• Phase: N/A
• First received: May 29, 2015
• Last updated: November 6, 2017
• Start date: June 2017
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present research will pilot-test a new state-of-the-art Internet-based intervention targeting adherence facilitation and optimization of medication use, and will be evaluated to assess its utility in facilitating adherence and optimization of medication use for acute migraine pharmacotherapy. This is not an interventional study and will instead be an observational assessment of the feasibility of an online program (a proof-of-concept study). The two principal objectives of this study include: (a) examination of the feasibility and user usage patterns of an Internet-based intervention designed to potentially enhance adherence to medication use recommendations, and (b) determination of the efficacy of the Internet-based intervention in potentially increasing knowledge of abortive medication-use guidelines and in improving adherence to those guidelines. To meet the objectives of this study, a website has been specifically developed including a series of supplemental text-based headache materials and a series of videos based social learning theory and modeling principles (as opposed to the stereotypical 'talking-heads' mode of information delivery).

Description:

Objective 1. To examine the feasibility and user usage patterns/demand of an online intervention designed to enhance adherence and optimize abortive medication-use for migraineurs.

Goal 1: To evaluate the practical utility of an Internet-based user environment to host an intervention designed to increase knowledge of and facilitate adherence and optimize abortive medication use.

Hypothesis 1A: That an Internet-based user environment can be appropriately suited to deliver an adherence intervention that, in turn, could be made widely accessible and readily employed.

Hypothesis 1B: That a high proportion of patients referred to the adherence facilitation Web site will actually visit and make use of the adherence intervention Web site.

Hypothesis 1C: That once the Web-based intervention is initiated, a low attrition rate will be observed and the majority of patients will complete the intervention.

Objective 2. To examine the efficacy of an online adherence facilitation and medication optimization intervention in increasing knowledge of optimal abortive medication-use.

Goal 2: To conduct a pilot trial examining the efficacy of an adherence and medication optimization intervention for improving knowledge and medication-use behavior in a wide range of migraine sufferers.

Hypothesis 2A: That patients who complete the Web-based intervention will demonstrate improved knowledge of optimal abortive medication strategies at post-treatment and this knowledge will be maintained at follow-up.

Hypothesis 2B: That patients who complete the Web-based intervention will report improved abortive medication use strategies at post-treatment and this behavior change will be maintained at follow-up.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Adults >= 18 year-old

2. Any self-reported headache disorder, from any etiology ( > 5 attacks, lifetime)

3. Self-reported use of any headache abortive treatment:

• Over the counter (e.g., Ibuprofen, naproxen sodium, Excedrin, etc.)

• Prescription (Triptans, CGRP antagonist, Ibuprofen, etc.)

Exclusion Criteria

1. Inability to read and write English (the questionnaires are exclusively in English)

2. Inability to accurately complete questionnaire or provide informed consent: (e.g., Florid psychosis, Current intoxication)

3. No internet access

Related Conditions & MeSH terms

• Headache

Intervention

Other:
• Online Migraine Treatment Optimization
The educational videos entail a young woman (i.e., an actress) describing her experiences in managing her headaches. The informational content of the videos is organized into 7 content areas that present a wealth of information in an entertaining way: Introduction to the series Getting to know migraine Making the most of your medical care Partnering with your doctor Best use of migraine medication Keeping tabs on your migraine Take home message (summary)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility assessed by the practical utility of an Internet-based user environment to host an intervention designed to increase knowledge of and facilitate adherence to abortive medication use guidelines.	Feasibility will be demonstrated based on the number of participants who complete the online videos.	Post-intervention, at the end of the 1 week study period
Secondary	Attrition assessed by the rate of attrition from the study, determined based upon the number of enrolled participants who do not complete the online video portion.	Attrition assessed by the rate of attrition from the study, determined based upon the number of enrolled participants who do not complete the online video portion.	Post-intervention, at the end of the 1 week study period